DB-1303

DB-1303 (also known as BNT323) is a next-generation antibody-drug conjugate (ADC) targeting the Human Epidermal Growth Factor Receptor 2 (HER2). Developed by Duality Biologics using its proprietary DITAC (Duality Immune Toxin Antibody Conjugate) platform and co-developed with BioNTech, the molecule consists of a humanized anti-HER2 monoclonal antibody (traduxtamab, biosimilar to trastuzumab) conjugated via a cleavable peptide linker to a potent topoisomerase I inhibitor payload (P1003/F2F22C). DB-1303 is designed to exhibit high antitumor activity in both HER2-high and HER2-low expressing tumors, leveraging a bystander killing effect to target neighboring tumor cells. It has received Breakthrough Therapy Designation from the FDA for advanced endometrial cancer and is currently being evaluated in Phase 3 clinical trials for endometrial and breast cancers.

Other names

traduxtamabtraduxtamab vedotinHER2-targeted ADCHER-2-targeted ADCHER 2-targeted ADCBNT-323BNT323BNT 323